Terragene recalls

2 official recalls and safety alerts involving Terragene since 2024-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Terragene or the relevant agency.

1. 2025-03-05
2. US
   Drugs & medicalClass II

   TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

   Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.

   FDA · DeviceTERRAGENE S.A.US Nationwide distribution in the states of CA and KY.Official notice →
3. 2024-02-07
4. US
   Drugs & medicalClass II

   TERRAGENE S.A. recalls Terragene Bionova PCD (PCD222-C)

   Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

   FDA · DeviceTERRAGENE S.A.U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.Official notice →